Advanced methodologies for model-based optimization and control of pharmaceutical processes

Traditionally, the pharmaceutical industry relied on resource-intensive and empirical methods for process development, optimization, and control. Heuristic approaches to pharmaceutical development and manufacturing have led to an unsustainable number of drug shortages and recalls and to escalating costs for launching new drug products. Optimization and control strategies rooted on process modeling are helping to advance pharmaceutical manufacturing by reducing development times and manufacturing costs, improving productivity and quality control, and enhancing process understanding. This perspective discusses recent developments toward model-based optimization, state estimation, and control of pharmaceutical processes. Ancillary areas such as software tools, equipment and sensor technology, and process modeling are first covered. Then, several recent academic and industrial case studies are discussed to highlight workflows and benefits related to the implementation of model-based optimization, state estimation, and control in (bio)pharmaceutical manufacturing. Finally, strategies for overcoming current challenges in the real-world application of model-based optimization and control are discussed.